Moderate FDA (Devices)·Z-1445-2015·Announced 2015-04-22

Siemens Artis Q and Q zen Angiography Systems Recalled for Electrical Connection

Siemens is recalling 139 Artis Q and Q zen angiography systems nationwide because an electrical connection in the equipment cabinet may not be installed correctly.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential installation defect without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 139 Artis Q and Q zen systems, which are dedicated angiography systems used for diagnostic imaging and interventional procedures. The recall is due to a potential issue where an electrical connection in the equipment cabinet may not have been installed correctly.

The affected devices were distributed nationwide. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the inspection and correction of the electrical connection.

The recalled product

Product: Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiog
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Angiography Systems
Hazard: electrical-defect
Affected units: 139

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Model Number of device:10848280
10848281
10848282
10848283
10848353
10848354

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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